Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
|Publication Date:||1 March 2012|
|ICS Code (Other standards related to laboratory medicine):||11.100.99|
This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents.
This test method does not advocate an acceptable level of cleanliness. It identifies one technique to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.
Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods.
The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.
This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing.
NOTE 1-For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 10993-12.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This standard may involve hazardous or